A Prospective, Multicenter, Randomized Study Comparing Orbital Atherectomy to Other Calcium Modification Strategies in Patients with Severely Calcified Coronary Lesions

Coronary artery disease (CAD), also known as ischemic heart disease, is the leading cause of mortality worldwide, contributing to 108 deaths per 100,000 people and 2,275.9 disability-adjusted life years (DALYs) per 100,000. The World Health Organization reports that cardiovascular diseases account for 17.9 million deaths annually.  In India, the prevalence of CAD is approximately 10.5%, higher than the global average of 8.8%. The increasing burden of CAD, driven by risk factors such as diabetes, hypertension, dyslipidemia, and smoking, has led to a growing need for revascularization procedures, particularly percutaneous coronary intervention (PCI).

Percutaneous coronary intervention (PCI) has significantly advanced the management of CAD by restoring coronary blood flow. However, the higher prevalence of coronary artery calcification (CAC) in PCI patients complicates this procedure. Severe CAC, present in 5.9% to 20% of PCI patients, obstructs stent delivery and deployment, hindering optimal stent expansion and increasing the risks of early complications such as vessel closure, slow flow, dissection, perforation, stent dislodgement, and embolization, as well as late complications like stent thrombosis, in-stent restenosis, and aneurysm formation. To address these challenges, advanced plaque-modification strategies, such as orbital atherectomy (OA), rotational atherectomy (RA), intravascular lithotripsy (IVL), and cutting or scoring balloons, are employed based on lesion characteristics, the patient’s clinical condition, and the operator’s expertise.

The Diamondback 360® Coronary Orbital Atherectomy System (OAS) by Cardiovascular Systems Inc., approved by the US Food and Drug Administration (FDA) in late 2013, represents a significant advancement in the treatment of severely calcified coronary artery lesions. Specifically indicated for de novo, severe CAC, OA is the only FDA-approved device designed to improve stent delivery by addressing heavily calcified lesions. This innovative technology utilizes a bi-directional burr passage and elliptical propagation, which reduces the risk of burr entrapment, making it an essential tool for interventional cardiologists. Recognized for its efficacy in preparing coronary lesions for PCI, OA has become critical in managing complex CAD with severe calcifications. The 2021 ACC/AHA/SCAI guidelines further endorse the use of OA to improve procedural success and optimize patient outcomes in these challenging cases.

Despite its growing use, the comparative effectiveness of OA versus other calcium modification techniques has not been sufficiently evaluated in large-scale studies. This prospective, multicenter, randomized study aims to compare the clinical, technical, and economic outcomes of OA with other calcium-modifying devices in patients with severely calcified coronary lesions. The study will address the need for evidence-based guidelines for managing these high-risk lesions and provide insights into the cost-effectiveness of OA compared to other strategies.